Some active principles exhibit unacceptable organoleptic properties and, as a result, are unsuitable for preparing pediatric or oral formulations intended for individuals in whom swallowing is difficult and can pose problems. For these reasons, some major products are deprived of a pediatric formulation and, in addition, some individuals are deprived of treatment using these active principles, which may have extremely prejudicial, or even vital, consequences.
The problem of masking taste has always been a considerable problem for the pharmaceutical industry. Antibiotics, often given to children for numerous childhood illnesses, are particularly plagued with this problem. Many systems have been tried, but in the case of active principles which are too bitter, coating systems have mostly proved to be insufficient and particulate systems, when they are more effective, exhibit drawbacks of too great a particle size, leading to a sandy aspect in the mouth and to the patient refusing the medicinal product.
In European patent EP 639365, a method has been described for preparing coated particles by spray-coating using a molten wax sprayed via a two-fluid nozzle. However, this method is based on spraying molten wax onto particles, so as to form a coating. No mixing of the active principle is carried out beforehand with the wax; in addition, the particles and the nozzle have large diameters. Finally, tests according to the method of the present invention, based only on the use of a molten wax, have not given acceptable results in terms of kinetics of release at pH=1.
It has now been found that compositions intended for oral administration can be developed and provide a masking of taste which is sufficient to be acceptable and to allow in particular the administration of pharmaceutical compositions to young children or to individuals not able to swallow.